510(k) K153470 ยท CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
MADgic Laryngo-Tracheal Mucosal Atomization Device
| Applicant | Teleflex Medical, Morrisville NC, US |
| Decision | Substantially Equivalent, Aug 19, 2016 |
| Received | Dec 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153470
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2017 | Teleflex Medical LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c)
MAD720 MADgic
Intended for the application of topical anesthetics to the oropharynx and u Terminated |
CCT | None listed |
| Nov 9, 2016 | Teleflex Medical FLEXI NOZZLE SHORT
Product Usage:
These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recallin Terminated |
CCQ | None listed |
| Nov 9, 2016 | Teleflex Medical LMA MADgic, Atomization Device with 3mL Syringe, Rx only,
Product Usage:
These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryng Terminated |
CCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.